Nasal Mucin Oral Supplementation Treatment Respiratory Inflammation Using PUFA in Cystic Fibrosis (CF) Patients (NOSTRIL)
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|ClinicalTrials.gov Identifier: NCT01329172|
Recruitment Status : Terminated
First Posted : April 5, 2011
Last Update Posted : December 22, 2017
Cystic fibrosis (CF) patients are prone to recurrent pulmonary infection have different secreted mucin pattern from healthy subjects. Long chain polyunsaturated fatty acids have been shown to influence survival and MUC5B expression in mice model of chronic pulmonary infection.
To study the impact of LCPUFA n-3 on MUC5B expression (mRNA level by RT-PCR) collected in airway epithelial cells obtained by nasal brushing. The secondary aim is to assess : MUC1, MUC2, MUC4, MUC5AC, MUC7 expression (mRNA level) in airway epithelial cells obtained by nasal brushing; Lund-Kennedy score; TNK-alpha, IL-6, IL-8 in blood plasma. This study is a double parallel, controlled double blind, randomized clinical trial : LCPUFA n-3 (1 g/day) vs placebo for 6 weeks. 30 subjects will be included in this study. Primary and secondary study end point will be assessed two times: before randomization and after 60 days of treatment.
Statistical analysis :
Treatment group and placebo will be compared using U-Mann-Whitney, intention to treat and per protocol.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Dietary Modification||Other: polyunsaturated fatty acids n-3 Other: placebo||Not Applicable|
Primary Outcome Measure : Mucin MUC5B (mRNA level) in native airway epithelial cells obtained by nasal brushing
Secondary Outcome Measures : Mucin MUC1, MUC2, MUC4, MUC5AC, MUC7 (mRNA level) in native airway epithelial cells obtained by nasal brushing.
Lund-Kennedy score TNF-alpha, IL-6, IL-8 in plasma
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Impact of Polyunsaturated Fatty Acids n-3 on Nasal Mucins Expression in Cystic Fibrosis Patients|
|Actual Study Start Date :||September 20, 2010|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
Experimental: polyunsaturated fatty acids n-3
polyunsaturated fatty acids n-3 (PUFA n-3)
Other: polyunsaturated fatty acids n-3
polyunsaturated fatty acids n-3 1 gram per day during two months
Other Name: PUFA n-3
Placebo Comparator: placebo
sun flower oil
sun flower oil with Poly Unsaturated Fatty Acid 1g/day
Other Name: PUFA
- Expression of Mucin "MUC5B" by measurement of messenger Ribo Nucleic Acid (mRNA) level in native airway epithelial cells obtained by nasal brushing [ Time Frame: baseline and 2 months ]
- Mucin MUC1, MUC2, MUC4, MUC5AC, MUC7 (mRNA level) in native airway epithelial cells obtained by nasal brushing. Lund-Kennedy score TNF-alpha, IL-6, IL-8 in plasma [ Time Frame: baseline and two months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329172
|Lens, France, 62300|
|Clinical Investigation center|
|Lille, France, 59037|
|Study Chair:||Frédéric GOTTRAND, MD, PhD||CHRU de Lille et Université Lille 2|